Recent advances in medical technology, surgery techniques, and supportive healthcare have enhanced the survival rate for babies born prematurely or with life-threatening conditions. A further consequence of these trends is substantially more newborns experiencing severe post-surgical pain.
Babies Feel Pain
Until about three decades ago, it was not clear that the developing nervous system of neonates could experience severe pain.
Today we know they do — infants experience similar levels of pain as adults.
Treatment of Pain in NICU
The current procedure is after surgery neonates admitted to neonatal intensive care units (NICU) experience severe post-surgical pain, followed by treatment with narcotics (opioids) such as fentanyl or morphine. There is no doubt these narcotics reduce pain; however, they also appear to cause a major rewiring of the infant’s neurological pathways for pain and addiction.
The Way It Wires, the Way It Fires
The current cycle (pain>narcotics>dependence>pain,narcotics…) appears to rewire the infant’s developing nervous system, causing unwanted changes that continue well past discharge from NICU.
For instance, infants treated with opioids for post-surgical pain experience stunted brain development, impaired learning, and more mental health issues, including higher rates of addictive behaviors, as adolescents and adults.
Other unwanted side effects of treating newborns with opioids is dependence, which leads to an extended period of withdrawal that endangers the infant’s health, as well as imposes further emotional and financial costs for families, care-givers, and NICUs.
AI-based EPD — Stay Ahead of the Pain
Our solution, Artificial Intelligence (AI)-based Early Pain Detection (EPD), is designed to warn of impending post-surgical pain at least 30 minutes prior to the pain onset. This approach allows health care workers in NICU to administer non-opioid approaches — intravenous acetaminophen, ibuprofen, or gabapentin — to prevent the onset of pain in the first place, as well as the subsequent opioid dependence and withdrawal. A further attribute of EPD is continuously monitors pain, which alleviates busy NICU nurses from this difficult, subjective and error prone responsibility.
EPD Hardware
The EPD system requires minimal, low-cost equipment all located a safe distance from the baby: one camera with a microphone aimed at the infant’s face, the other on the body; and vital signs (BP, HR, RR, SpO2) from a bedside monitor. These data are fed to a nearby laptop that synchronizes the vital signs (VS) with facial expression, body movement, and crying frequency for predicting the time to onset of pain using our AI approach.
AI Predicts Natural but Non-Random Events
In addition to EPD, AI is currently used to predict other natural but non-random events such as thunderstorms, crop yields, and future trajectories of medical conditions such as kidney disease, diabetes, and heart attacks. Reliable AI-based predictions allow time for preparations that prevent or mitigate economic loss and/or physical damage.
Potential Benefits of EPD
EPD allows for proactive use of fast-acting non-opioids to “flatten the curve” of the recurring cycle of intermittent post-surgical pain, narcotic treatment, and opioid withdrawal (larger peaks/valleys), leading to less toxic stress (smaller peaks/valleys) in neonates.
The EPD Team
Our Clinical Biotechnology group at SRC Biosciences and the University of South Florida in Tampa, Florida includes physicians, medical scientists, NICU nurses, and computer programmers. Extended members of our EPD team include experts in infant pain management at Stanford University, as well as future data collection sites in the US, Europe and Israel.
Investor Information
The EDP approach is under development with federal support from the National Institutes of Health. Data collection is based at Tampa General Hospital with testing, validation, and project management at SRC Biosciences and USF. The availability of an EPD prototype for beta testing is expected by July 2022.
Life-Saving Surgery without the Pain
EPD allows NICU staff to “stay ahead” of post-surgery pain and use fast-acting non-opioid pain-preventing medication to avoid the pain cycle before it starts. Once deployed, this system and approach will allow newborns to receive life-saving surgery while avoiding the damaging effects of severe pain, followed by treatment, dependence, and withdrawal from powerful narcotics.
Contact Us
Potential investors and others seeking further information on EPD may Contact Us at SRC@neonatalpain.com.